BIOMEDICINE AND HEALTH
RESEARCH
1994 - 1998
WORKPROGRAMME BIOMED 2
sm/mv/wp2nd.en3
TABLE OF CONTENTS
WORK PROGRAMME
I
Introduction
5
II
Technical areas
7
III
Special means of action particular to the BIOMED 2 programme
13
IV
Modalities
15
ANNEX 1
DETAILED SCIENTIFIC CONTENTS
AND IMPLEMENTATION
OBJECTIVES AND RESEARCH TASKS
AREA 1 AREA 2 -
AREA 3 AREA 4 -
AREA 5 AREA 6 -
AREA 7 -
II.
21
PHARMACEUTICALS RESEARCH
RESEARCH ON BIOMEDICAL TECHNOLOGY AND
ENGINEERING
28
BRAIN RESEARCH
RESEARCH ON OTHER DISEASES WITH MAJOR SOCIOECONOMIC IMPACT
FROM BASIC RESEARCH INTO CLINICAL PRACTICE
45
48
RESEARCH ON BIOMEDICAL ETHICS
IMPLEMENTATION OF THE WORKPROGRAMME
30
33
HUMAN GENOME RESEARCH
PUBLIC HEALTH RESEARCH, INCLUDING HEALTH
SERVICES RESEARCH
25
54
sm/mv/wp2nd.en3
49
I INTRODUCTION AND GENERAL OBJECTIVES
This Workprogramme is in accordance with Article 5 of the Council Decision adopting
the BIOMED 2 programme and reflects the approach embodied in the fourth
framework programme, applies its selection criteria and specifies its scientific and
technological objectives. Paragraph 4.B. of Annex III, first activity of the framework
programme, is an integral part of this Workprogramme. It will be implemented in
synergy between other specific programmes in the field of Life Sciences and
Technologies, as well as in such fields as Telematics, Measurement and Testing, and
Targeted Socio-economic Research.
Within BIOMED 2 it is intended to go beyond just the coordination of research but,
where appropriate, directly fund RTD research projects. Horizontal activities will
involve demonstration projects and analysis of ethical, social and legal aspects in the
biomedical and health research field.Furthermore, specific exploratory measures (such
as funding of studies and surveys, workshops and conferences) together with
appropriate training activities (e.g. fellowships, targeted summer courses) will be
taken.
The recently established Task Force on Vaccines and Viral Diseases, has set a
number of priorities for R&D in these fields as a result of a broad consultation targeted
to governments, industry and academia and several specific meetings with interested
actors. These priorities should be reinforced within the specific work programmes
involved in vaccine development including BIOMED 2. Finally, efforts will be made to
disseminate, exploit and publish the research results adequately.
Only those proposals with a sound scientific concept, a clear Community added value
and a contribution to make to the health and wealth of the European citizen will be
selected.
No support will be provided to projects which may contravene elementary principles of
the European Convention on Human Rights, the Charter of United Nations and the
future Bioethics convention of the Council of Europe, when adopted.
The programme has a general objective to contribute to the improvement of the health
of the citizen and population as well as strengthening the scientific basis of the
competitiveness of the European health industry. As such, the workprogramme
targets the research towards projects of interest to the Community and consumers,
and promotes the transfer of research into clinical practice.
In line with article 129 of the Treaty,a close interaction is being established between
the public health research activities of this programme and the public health actions of
the Community with attention being paid to the objectives of the specific programmes
based on this article. Similarly a close link will be established between research on
occupational health and the Commission's activities in health and safety at work.
1
sm/mv/wp2nd.en3
The workprogramme will focus on important issues linked to :
-the fight against major problems such as AIDS, cancer, cardiovascular disease,
mental and neurological diseases, etc;
-
the rising health care costs and the need for high quality health care;
-
the introduction of new medicines, health technologies and health care
systems;
-the interaction of all disciplines from basic to clinical research.
The objectives and research tasks are described in the annex to this workprogramme
and address the following areas:
-
pharmaceuticals research,
-
research on biomedical technology and engineering,
-
brain research,
-
research on other diseases with major socioeconomic impact (from basic
research into clinical practice) including:
-
cancer research,
research on AIDS, tuberculosis and other infectious
diseases,
research on cardiovascular diseases,
research on chronic diseases, ageing and age-related problems,
research on occupational and environmental health,
research on rare diseases,
-
human genome research,
-
public health research, including health services research,
-
research on biomedical ethics.
2
sm/mv/wp2nd.en3
II
TECHNICAL AREAS
AREA 1
PHARMACEUTICALS RESEARCH
The general objective is to develop the scientific and technical basis required for the
evaluation of new drugs and vaccines notably for the treatment of neurological,
mental, immunological and viral diseases. These research actions should also
underpin the activities of the European Medicines Evaluation Agency. The contribution
of functional imaging to neuropharmacology research will also be explored.
Research in the field of pharmacotoxicology, pharmacovigilance, clinical trials and illicit
drug abuse will be undertaken through collaboration between industry, research
centres, hospitals, universities and the authorities responsible for verifying the efficacy,
safety and quality of medicines, including vaccines.
In the field of pharmacotoxicology, topics will include: in vitro models of drug
metabolism and biokinetics preferably using human cells and tissues, the mechanisms
of cell-specific toxicity (with a special attention to toxicology during embryonic and
foetal development, neurotoxicology and drug allergies)
Research in pharmacovigilance will address drug utilisation and drug exposure in the
European population and design and conduct of case-control and cohort studies for
hypothesis testing and meta-analysis; initiatives encouraging the use of appropriate
safety measures in post-approval controlled studies will be considered.
In the field of clinical trials, research will focus on better methodologies for randomised
clinical trials, including systematic reviews and meta-analysis, and development of
methodologies for the definition and validation of surrogate end-points. Research on
the treatment of rare diseases, including methodologies for fast-track schemes in the
development of orphan drugs, will also be included.
AREA 2
RESEARCH
ENGINEERING
ON
BIOMEDICAL
TECHNOLOGY
AND
A faster transfer of research results by medical engineering into clinical practice will be
obtained by integration of basic and applied research in biomedical devices,
instruments and techniques as well as in cellular engineering, in order to develop or
improve diagnostic or therapeutic tools, methods and standards.
Research topics in this area will include standardisation of minimal intervention
techniques, imaging systems and other devices and techniques for diagnosis and
therapy, biosensor systems, development of tools which contribute to the
rehabilitation, replacement or restoration of human function, and finally developments
in cellular engineering.
Priority will be given to projects which exhibit a close integration between engineering
and medicine.
3
sm/mv/wp2nd.en3
AREA 3
BRAIN RESEARCH
The new capabilities created by molecular biology and genetics, novel instrumentation
and information technologies will be brought together to allow a better understanding
of the brain function at molecular and cellular level and a better characterization of
brain structures, functional units and metabolic pathways in normal and pathological
situations.
The primary objective of research in this area is to understand the functions of the
brain and the basic mechanisms underlying mental and neurological diseases by
integrating molecular, cellular and clinical approaches.
More specifically, research will be undertaken on nervous system damage and repair
in relation to disease development, the genetic and immunological basis of brain
disease development, the establishment of cell cultures, and where necessary animal
models of the human brain diseases. Research will also focus on the development of
new methods of brain imaging.
Clinical research will be undertaken, mainly focused on clinical trials, treatment of
neurological, sensory and psychiatric diseases, and their prognosis and progression,
and on the impact of therapeutic procedures.
Furthermore, research on mechanisms of pain regulation and relief, and biological
effects of illicit drugs on the structure and function of the brain will be addressed.
Development of combined epidemiological and long-term prevention programmes to
evaluate the impact of neurological and mental diseases will be undertaken. Finally,
research will be supported on cognitive sciences including the development of models
of neuronal behaviour, learning, memory and neurolinguistics.
AREA 4
RESEARCH ON DISEASES WITH MAJOR SOCIO-ECONOMIC
IMPACT. FROM BASIC RESEARCH INTO CLINICAL PRACTICE
AREA 4.1
CANCER RESEARCH
Improvements in cancer diagnosis, therapy and prevention require integrated
fundamental and clinical approaches to research. It is particularly important to bring
new advances in cellular, molecular and developmental genetics into contact with
oncology and epidemiology, in order that new biological insights into the underlying
causes of cancer allow for the development of interactive novel approaches. Studies
of host-tumour interaction in the context of immune response and of somatic gene
therapy targeted at cancer cells are fundamental, together with epidemiological
studies for investigating possible causative factors in carcinogenesis.
Research will be conducted on molecular mechanisms of tumorigenesis and
metastasis, on the control of normal cellular growth, differentiation and death, and
abnormalities which can alter these to predispose to cancer, and on specific antitumour immune responses and possibilities for early detection. Furthermore, research
will be undertaken to support the effectiveness of systemic treatment, the therapeutic
4
sm/mv/wp2nd.en3
ratio of radiotherapy and the field of ballistic selectivity. Finally the quality of life as a
parameter for treatment assessment will be addressed.
AREA 4.2
RESEARCH
INFECTIOUS DISEASES
ON
AIDS,
TUBERCULOSIS
AND
OTHER
Research in this area will include the full spectrum of research tasks needed to
reinforce the fight against AIDS and other emerging diseases or re-emerging
infectious diseases. This implies focusing on the integration of basic, clinical and
epidemiological research, with the clear objective of developing safe and effective
vaccines and improving existing and developing new therapies, and defining the extent
of the emerging problems.
Viro-immunological research, as well as research on the pathogenesis of HIV and
other infections, will be undertaken. The development of safe and effective vaccines
against HIV and other infections will be supported.
Research on the synthesis and evaluation of therapeutic compounds and clinical
research, including clinical trials, will be encouraged.
Disease prevention, including specific epidemiological studies and screening, will be
supported together with behavioral and socio-economic research related to AIDS and
other infectious diseases.
AREA 4.3
RESEARCH ON CARDIOVASCULAR DISEASES
Multidisciplinary research including cellular, molecular, genetic and clinical approaches
will be undertaken in order to contribute to the understanding of the physiopathological
mechanisms leading to cardiovascular disease development, in particular those of
high prevalence such as atherosclerosis and hypertension. In this context research
on the following topics will be addressed: cellular and molecular mechanisms leading
to disease, vascular and cardiac cell growth and repair, genetic basis of cardiovascular
diseases, clinical research including clinical trials, validation of preclinical screening,
imaging and non-interventional techniques, epidemiology and prevention.
AREA 4.4
RESEARCH ON CHRONIC DISEASES, AGEING AND AGERELATED DISEASES
Research in this area should lead to solutions for the large socio-economic burden of
chronic disease, handicaps and dependency. Investigations will be undertaken on the
aetiology and treatment of chronic diseases such as chronic arthritis, diabetes
mellitus, asthma and other respiratory problems. Furthermore, congenital and genetic
diseases will be addressed from the point of view of prevention and new therapeutic
approaches.
Research should concentrate not only on therapeutic measures as such but in
particular on the provision of help for handicapped and the improvement of quality of
life to be reached by medical interventions.
5
sm/mv/wp2nd.en3
AREA 4.5
HEALTH
RESEARCH ON OCCUPATIONAL AND ENVIRONMENTAL
Research in this area is aimed at improving the scientific knowledge needed to
increase the safety and health protection of workers, with particular emphasis on the
prevention of occupational diseases and accidents at work.
Research will focus on the epidemiology of accidents and occupational diseases with
special emphasis on low level exposures to chemical, biological and physical agents at
work as well as mixed exposures. Research will also cover the improvement of the
health and safety services, and the evaluation of the economic impact of accidents.
Furthermore, research on the interaction between risk factors at the workplace and the
environment and the aetiology of occupation- and environment-related diseases will
be addressed.
AREA 4.6
RARE DISEASES
Basic and clinical research into pathogenesis, genetic aspects and prevention of rare
(low prevalence) diseases will be pooled in order to arrive at a critical mass of
information. Research in this field will have to interlink with other areas such as human
genome (e.g. inborn errors of metabolism), pharmaceuticals research (e.g. repository
of orphan drugs) and public health research and epidemiology (e.g. inventory of rare
diseases).
AREA 5
HUMAN GENOME RESEARCH
Fundamental research in the area of human genome will be promoted. Emphasis will
be placed on functional studies in order to ensure that advances in genetics are used
to improve human health, combined with the development of appropriate technologies
and applications.
Topics for research will include: gene mapping and genome analysis, analysis of gene
function and regulation to determine gene-structure relationships and development of
model organisms, (e.g. the mouse), identification of determinants of
monogenic/multifactorial disease and understanding the role of genes in disease
aetiology and pathogenesis, as well as development of diagnostic and risk
assessment procedures for clinical use. Data handling and analysis to increase the
availability and usefulness of genome-related data will also be promoted. Somatic
gene therapy research will aim at establishing a scientific basis which will contribute to
the improvement of gene replacement and repair of human cells, with particular
emphasis on the development of methods to transfer genetic material safely and
effectively for therapeutic purposes.
The confidentiality of any personal information collected in the course of the research
must conform to the best data protection practice. No research modifying, or seeking
to modify, the genetic constitution of human beings by alteration of germ cells or of
6
sm/mv/wp2nd.en3
any stage of embryo development which may make these alterations hereditary, will
be carried out under this programme. Ethical, legal and social aspects will be dealt
with by both programme-specific (biomedical ethics) and horizontal activities.
AREA 6
PUBLIC HEALTH
SERVICES RESEARCH
RESEARCH,
INCLUDING
HEALTH
Efforts in this field will concentrate on research in:
-health education and prevention, primary care, assessment of health needs, including
the needs of emerging dependency groups), performance measurements of
health policy initiatives and the evaluation of health technologies;
-co-ordination and comparison of European health data;
-standardisation of methods for outcome measurement of health care;
-the impact of the Internal Market on the supply of health care across internal frontiers;
regulations and deregulations as well as the balance between health systems
financed by the private and public sector;
-heath economics and methods of evaluation of the organisation of health systems;
-new health indicators and new techniques of modelling;
-health technology assessment, including the assessment of the costs, effectiveness
and broader impact of all methods used by health professionals to promote
health, prevent and treat diseases and improve rehabilitation and long-term
care.
AREA 7
RESEARCH ON BIOMEDICAL ETHICS
Research in this domain will address general standards for the respect of human
dignity and the protection of individuals in the context of biomedical research and its
clinical applications. Research will aim at understanding and answering both public
attitudes and diversity of viewpoints, at fulfilling a prospective role for new
ethical/social issues, and at understanding and identifying fundamental values at the
basis of ethical issues. Research will therefore address fundamental values, for
instance human dignity and integrity, consent, autonomy and privacy, freedom and
responsibility, concepts of risk, solidarity and social justice. Initiatives will be supported
on ethical issues related to research and its applications in real-life situations, on
"beginning and end of life" issues, on socio-economic aspects as well as
methodologies and structures in bioethics.
7
sm/mv/wp2nd.en3
AREA 8
HORIZONTAL ACTIVITIES
Biomedical ethics will be placed in the broader context of general legal, social and
ethical aspects common to life sciences and under discussion within other institutions.
Demonstration activities will be undertaken to transfer results from technology
producers to technology users (clinicians, patients and health care systems) and
overcome the technical and socio-economic barriers which new technologies and
practices can encounter on the way to the market and the patient.
8
sm/mv/wp2nd.en3
III
SPECIAL MEANS OF ACTION PARTICULAR TO THE BIOMED 2
PROGRAMME
A number of features are specific for the BIOMED 2 programme such as :
1)
One of the most important characteristics of the BIOMED programme is to
support research projects only where the Member States research activities
can be made more effective by working together than they would be left to act
alone, thus observing both the basic principle of subsidiarity and the need for
European added value. Concerted Actions are designed to encourage
collaboration between teams of interested researchers, bringing together their
accumulated expertise in a research network to find solutions to medical or
health problems common to all European Member States.
Past experience has shown that the EC appropriations have constituted less than 5%
of the total cost of the Concerted Action project, so there is a "CA multiplier
effect" of 20 to 1.
The funds provided by the EC in the framework of a CA are for :
-
administrative and scientific support following directly from the
needs of the concerted action , i.e. building and managing of the research
network for joint data gathering and/or experiments
- organising meetings of all types
- short-term international staff exchanges
- preparing and exchanging reference materials
- centralised data handling
-
disseminating information and results as early, fully and frequently as possible
through a wide range of publications.
In order to achieve the specific objectives and targets formulated within the contract
the concerted action network may be reinforced by a network resource centre
necessary for the performance of the coordination action. Such a resource
centre may inter alia organize targeted training of the human resources in order
to help perform the joint experiments or data gathering by the participating
laboratories.
2)
As in the past, the BIOMED programme will use anonymous peer review.
Selection of projects will take account of criteria including the quality of
science, subsidiarity, Community added value, relevance to programme targets
and contribution to the health and wealth of the European citizen and industry,
as well as synergy with national research programmes and relevance to
Community action programmes in these areas.
9
sm/mv/wp2nd.en3
3)
It is intended that the established concerted action networks can now go further
in training young researchers. Targeted research training initiatives are
foreseen including bench fees and return grants in the form of laboratory
materials equipment for returning trainees.
4)
In order to enable standardisation, joint experiments, comparable data
collection and analysis, with access to particular quality control
products,experimental materials and specialised services, Eurofacilities
(or centralised facilities) can be set up as a general service tool for other concerted
or shared-cost actions of the Community. The Community funding can cover up
to 100% of the cost of the services rendered to European research centres,
universities, undertakings and enterprises participating in other actions.
5)
Within BIOMED 2 it is intended to go beyond concertation, including
centralised facilities and targeted training, and to participate in sharedcost research where indicated only for specific task-oriented research.
10
sm/mv/wp2nd.en3
IV
MODALITIES
Implementation modalities
This programme will be implemented through indirect actions of the following types:
concerted actions, specific measures, shared-cost actions, and
preparatory
accompanying and support measures. Details on these modalities are given in the
annex to this workprogramme.
Interprogramme coordination
This programme will be implemented in synergy with other programmes under "Life
Sciences and Technologies"(LST) as well as with others as Telematics, Measurement
and Testing, and Targeted Socio-economic research. The coordination will be carried
out by preview of technical annexes prior to selection by small coordination groups
composed of representatives from all three LST specific programmes and other
programmes as appropriate. Such groups will be established first in the following
topics where the possibilities of synergies look most promising: genome analysis,
neurosciences and brain research, transdisease vaccinology, pharmaceuticals
research, plant and animal health, biomedical ethics, biomedical engineering,and
health and safety of workers. The attached table 1 indicates where synergy and
coordination is foreseen.
Furthermore, similar synergy and coordination is foreseen with other activities of the
EU, such as in the field of public health, in line with article 129 of the Treaty,in the field
of health and safety at work, and with the European Medicines Evaluation Agency
(EMEA), as well as with activities in other frameworks, such as EUREKA and COST
will be established.
Financial provisions and calls for proposals
The attached table 2 describes the calendar of events for calls for proposals, with their
financial provisions. Table 3 shows the budget breakdown per area.
11
sm/mv/wp2nd.en3
Table 1
INTERPROGRAMME COORDINATION : BIOMEDICAL AND HEALTH RESEARCH
TAP
CT
IT
ITMT
SMT
MAST
BT
AF
NNE
T
TSER
CTC
DE
ST
ALL
ALL
Sub-areas
PHARMACOLOGY
P
P
P
BIOMEDICAL
TECHNOLOGY
P
BRAIN
P
P
P
AIDS+INF. DISEASES
P
P
P
CANCER
P
OCCUP. ENVIRON.
P
P
P
HUMAN GENOME
P
PUBLIC HEALTH
P
ETHICS
P
ENV/CL
IM
P
P
P
P
P
P
P
sm/mv/wp2nd.en3
OTHER RTD PROGRAMMES
TAP:
CT:
IT:
ITMT:
SMT:
Telematics Applications Programme
Communication technologies
Information technologies
Industrial technologies and material technologies
Standardization, measurement and testing
MAST:
Marine sciences and technologies
BT:
Biotechnology
BM:
Biomedicine and health
AF:
Agriculture and fisheries
NNE:
Non-nuclear energy
T:
Transport
TSER:
Targeted socio-economic research
CTC:
Cooperation with third countries and international organizations
DE:
Dissemination and exploitation of results
ST:
Stimulation of the training and mobility of researchers
ENV/CLIM: Environment and climate
MEANS OF COORDINATION
P = Preview of technical annexes prior to selection
sm/mv/wp2nd.en3
Table 2
FINANCIAL PROVISIONS AND CALL FOR PROPOSALS
Activity
Indicative
budget1
First call
1) Concerted actions
2) Shared cost actions2
3) Specific measures
153.7 MECU
Areas
Call opens
Deadline
Review and
selection of
proposals
Likely start of
commitments
Likely start
of contracts
All
15/12/96
31/03/95
15/09/95
Oct. 95
Jan. 96
First train
(33 MECU)
November 95
Second train
(120.7 MECU)
01/03/96
Second call
1) Concerted actions
2) Shared cost actions2
3) Specific measures
76 MECU
Third call
1) Concerted actions
2) Shared cost actions2
3) Specific measures
Fellowships
1
2
1, 2, 3, 4.2, 5
15/03/96
17/06/96
Dec. 96
March 97
Third train
(76 MECU)
01/03/97
81.8 MECU
4.1, 4.3, 4.4, 4.5,
4.6, 6, 7, 8.1
17/09/96
17/12/96
(Actions carried out
until end 2001)
April 97
97-98
Fourth train
(81.8 MECU)
01/01/98
6.8 MECU
6.8 MECU
4.3 MECU
Area 1,2,3,5
Area 4,6,7,8
All
Open call
1/04/96
31/12/96
31/12/97
30/06/96
31/03/97
31/03/98
July 96
April 97
April 98
30/09/96
30/06/97
30/06/98
The Amount Deemed Necessary of 358 MECU is ventilated between 329.44 MECU for interventions, including training, plus 28.56 MECU for personnel and administrative costs.
Including demonstration projects.
sm/mv/wp2nd.en3
15
sm/mv/wp2nd.en3
Table 3
INDICATIVE BREAKDOWN OF THE AMOUNT DEEMED NECESSARY
INDICATIVE PERCENTAGE3
AREA
MAIN MODE OF IMPLEMENTATION4
.
Pharmaceuticals research
11%
SC
.
Research on biomedical technology and engineering
11%
SC
.
Brain research
12%
SC
.
Research on diseases with major socio-economic impact: from basic research into clinical practice
Cancer research
Research on AIDS, tuberculosis and other infectious diseases
Research on cardiovascular diseases
Research on chronic diseases, ageing and age-related problems
Research on occupational and environmental health
Research on rare diseases
42%
CA
10%
8%
8%
10%
4%
2%
Human genome research
12%
SC
Public health research, including Health Services Research
10%
CA
Research on biomedical ethics
2%
CA
TOTAL
100% 5
sm/mv/wp2nd.en3
3
4
5
This breakdown does not exclude the possibility that a project could relate to several areas.
CA: mainly concertation; SC: mainly shared-cost actions.
Up to 5% of the funds will be allocated to horizontal demonstration activities; up to 1% of the funds will be allocated to horizontal activities on ethical, social and
legal aspects; up to 5% of the funds will be allocated to training activities.
Annex 1
Detailed scientific contents
and implementation
sm/mv/wp2nd.en3
Detailed scientific contents and implementation
I. OBJECTIVES AND RESEARCH TASKS
AREA 1
PHARMACEUTICALS RESEARCH
AREA 2
RESEARCH ON BIOMEDICAL TECHNOLOGY AND ENGINEERING
AREA 3
BRAIN RESEARCH
AREA 4
RESEARCH ON OTHER DISEASES WITH MAJOR SOCIOECONOMIC IMPACT - From basic research into clinical practice.
4.1
CANCER RESEARCH
4.2
RESEARCH ON AIDS, TUBERCULOSIS, AND OTHER INFECTIOUS
DISEASES
4.3
RESEARCH ON CARDIOVASCULAR DISEASES
4.4
RESEARCH ON CHRONIC DISEASES, AGEING AND AGERELATED DISEASE
4.5
RESEARCH ON OCCUPATIONAL AND ENVIRONMENTAL HEALTH
4.6 RARE DISEASES
AREA 5
HUMAN GENOME RESEARCH
AREA 6
PUBLIC HEALTH RESEARCH, INCLUDING HEALTH SERVICES
RESEARCH
AREA 7
RESEARCH ON BIOMEDICAL ETHICS
AREA 8
HORIZONTAL ACTIVITIES
8.1
8.2
ETHICAL, LEGAL AND SOCIAL ASPECTS
DEMONSTRATION ACTIVITIES
II. IMPLEMENTATION OF THE WORKPROGRAMME
1.
2.
3.
4.
Concerted actions.
Shared-cost actions.
Specific measures.
Fellowships.
18
sm/mv/wp2nd.en3
I.
OBJECTIVES AND RESEARCH TASKS
AREA 1
PHARMACEUTICALS RESEARCH
The general objective of this part of the workprogramme is to develop the scientific
and technical basis required for the evaluation of new drugs, notably for the
treatment of neurological, mental, immunological and viral illnesses. Research
actions should provide scientific underpinning of the activities of the European
Medicines Evaluation Agency. Research will be conducted through collaboration
between industry, research centres, hospitals, universities and the authorities
responsible for verifying the efficacy, safety and quality of new drugs, including
vaccines, while respecting the ethical, legal and social aspects of medical research.
The contribution of functional imaging to neuropharmacology research will also be
explored.
1.1
Pharmacotoxicology
OBJECTIVES
The general objective will be to improve and assess systems for evaluating quality,
safety and efficacy in the development of pharmaceuticals and vaccines, in order to
overcome hurdles which could delay marketing of new drugs in the EU. Research in
the field of in vitro and in vivo pharmacotoxicology aims to develop tests or models for
predicting the specific effects of chemicals which are likely to occur following the
exposure of man. The predictability of the various models concerns, in many cases, a
rather narrow aspect of a particular biological process. Integrating information from
complementary in vitro as well as in vivo models will make significant contributions to
risk or therapeutic assessment. In that context, a scientific pre-validation which
requires analysis of the biomechanisms at work in the in vitro tests and models is
essential.
Research in the field of in vitro pharmacotoxicology aims to generate information
which will contribute to a more scientific assessment of drug risks or therapeutic
potential in vivo.
Prevalidation research will be carried out on in vitro alternative methods, possibly
using human cells and tissues, and where unavoidable animal models, with the
general aim of reducing, refining and replacing animal experimentation, progressively
and each time it is scientifically possible, also making use of mathematical modelling
systems. Preference will be given to those tests which have reached the most
advanced stage towards validation such as those developed within the Biotechnology
Programme. Prevalidation research on these tests should ideally provide the
European Centre for the Validation of Alternative Methods with the best candidates for
proper validation studies.
2
sm/mv/wp2nd.en3
RESEARCH TASKS INCLUDE
1.1.1 To explore the relationships between chemical structure, pharmaco-and
toxicokinetics and safety of a new drug or vaccine.
1.1.2 Research on in vitro models of drug metabolism and biokinetics, preferably
using human cells and tissues and purified enzymes-including non-hepatic
tissues-, relevant to safety assessment.
1.1.3 Research on quantitative relationships between plasma concentration and
desirable and undesirable drug effects, including allergic and other immune
responses to drugs.
1.1.4 Research into biochemical mechanisms of pharmacologically induced cell
necrosis and apoptosis including early markers of cell death.
1.1.5 Research into the contribution of functional imaging to neuropharmacology
research, specificity on advanced visualisation techniques in studies on drug
safety.
1.1.6 Research on safety issues concerning the use of somatic gene therapy in
preclinical and clinical research.
1.1.7 Novel drug discovery methodologies with emphasis on development of new
ligands for potential drug targets.
1.1.8 Research in pharmaceutical aspects of illicit drug demand reduction, including
doping in sports.
1.1.9 Studies on non-animal toxicology and methodologies in vaccine research.
1.2
Pharmacovigilance
OBJECTIVES
Given the inherent limitations of pre-marketing testing in defining the risks of (new)
medicines, the detection and evaluation of unwanted drug effects, which may become
manifest only after marketing, is a requirement in all Member States. It is widely
recognized that these varied national pharmacovigilance systems play a pivotal role in
the identification and monitoring of adverse drug reactions (ADR). Hence the
development of systems for high performance surveillance networks for early
detection of possible undesired effects of new medicines is needed in accordance with
the existing regulatory framework and with particular attention to international
harmonisation efforts.
RESEARCH TASKS INCLUDE
3
sm/mv/wp2nd.en3
1.2.1 Research into drug utilisation and drug exposure in the European population.
-
Monitoring ADR in the hospital setting in close cooperation with other specific
programmes.
-
Surveillance of hospital population exposure to new biopharmaceuticals with a
view to determining their benefit/risk ratio.
-
Dose-effect relationship between previous drug exposure and the incidence
and severity of ADR.
-
Drug-associated emergencies in Europe.
-
Research into the relationships between drug exposure and drug effects in
cases of drug- related deaths.
-
Use of health statistics for pharmacoepidemiology.
1.2.2 The development of an on-line data base network for adverse drug reaction
reporting within Europe including an inventory of available registries.
1.2.3 Research and development of diagnostic terms, diagnostic criteria, assessment
and comparative data analysis in schemes for reporting spontaneous ADR.
1.2.4 Case control studies and cohort studies.
Design and conduct of case-control studies in the prospective
hypothesis-testing of suspected adverse drug reactions to new active
substances.
-
Critical examination of the use of techniques of meta-analysis for the
assessment of several case-control studies conducted with different protocols.
-
Disease-focused case-control studies (eg. in birth defects, acute anaphylaxis,
stroke, hepatitis, Guillain-Barré Syndrome, pulmonary fibrosis, etc.)
1.2.5 Research encouraging the use of appropriate measures of safety in
experimental, post approval controlled studies designed to investigate the
efficacy of new or established agents.
1.2.6 Pharmacovigilance on medical biotechnology products including vaccines in the
short and long term.
1.3
Clinical trials
OBJECTIVES
The organization of European multicentre networks for clinical trials including
Randomized Clinical Trials (RCT) are essential to establish efficacy and safety of
4
sm/mv/wp2nd.en3
treatments and medicines. Through RCT it is possible to stimulate, across EU
Member States, better methodologies, including those based on modelling systems,
resulting in improved diagnostic and therapeutic procedures. When the RCT are large
the results obtained can be rapidly spread with the advantage of a quick transfer from
research to practice and with important pharmaco-economic aspects.
RESEARCH TASKS INCLUDE
1.3.1 Research on methodologies leading to randomised clinical trials (RCT)
becoming more effective, more efficient, and more informative, which will
include improved methods for performing systematic reviews, including metaanalysis of RCT; influence of pharmacokinetic, pharmacodynamic and noncompliance variability among patients on clinical trial outcomes, methodologies
for conducting RCT in specific patient populations (children, elderly etc.).
1.3.2 Development of methodologies for the definition and validation of surrogate
end-points versus clinical end-points, including quality of life.
1.3.3 Research on the treatment of rare diseases, including methodologies for fasttrack schemes in the development of orphan drugs and repositories of
available orphan drugs in Europe.
1.3.4 Research on methodologies for protocol determination in clinical trials on
vaccines.
5
sm/mv/wp2nd.en3
AREA 2
RESEARCH ON BIOMEDICAL TECHNOLOGY AND ENGINEERING
OBJECTIVES
Coordination of basic and applied research in biomedical devices, instruments and
techniques as well as in cellular engineering, in order to develop or improve diagnostic
and therapeutic tools, methods and standards will contribute to further improve their
quality and reduce the cost of health care. A better and quicker transfer of research
results in biomedical engineering into clinical practice will be obtained by:
making clinicians aware of the possibilities offered by engineering (also
at cellular level), new technologies, methods and devices, and matching the
research and development with the needs expressed by physicians;
clinical assessment through clinical trials. Evaluations of medical
devices and methods (including cellular engineering techniques) should be
performed by competent networks of clinical research centres. Results will
provide essential information for decision making at all levels.
Priority will be given to projects which exhibit a close integration between engineering
and medicine.
RESEARCH TASKS INCLUDE
2.1
Progress and standardisation of minimally invasive intervention techniques with
the introduction of advanced technologies, including miniaturisation, 3D
imaging, robotics, videotechniques, microstructure technology and
nanotechnology to support surgery.
2.2
Research on imaging systems and other devices and techniques for diagnosis
and therapy in order to increase diagnostic power and possibilities of
simultaneous intervention.
2.2.1
Progress and standardization of techniques in medical imaging
techniques (e.g. in functional imaging, or in image processing and analysis
techniques).
2.2.2
Integration by multimodal imaging from a variety of methodologies, e.g.
magnetic resonance, ultrasound, position emission tomography, infrared,
fluorescence.
2.2.3
Progress and standardisation of techniques in diagnostic tools (e.g.
magnetic resonance, infrared spectroscopy), biosignal processing and analysis,
expert systems.
6
sm/mv/wp2nd.en3
2.2.4
Integration of information from various simultaneous measurements
(e.g. in critical care) in order to achieve a more comprehensive view of the
patient's status, to contribute to better and more rapid intervention. This
involves characterisation of parameters of a higher level of complexity that are,
finally, more meaningful for efficient diagnosis, therapy and improved health
care performance.
2.2.5
Development of monitoring systems and devices resulting in "intelligent"
diagnosis and improved therapy.
2.2.6
Improvement of devices for assessment of brain, sensory organs and
muscle function in particular, new monitoring methods for oxygen delivery and
consumption at organ or tissue level for acute care.
2.3
Development, application and clinical testing of sensor systems (including
physical, chemical, biological mechanical sensors, microsensors) for a variety
of metabolic functions, movements and signals.
2.4
Development of tools which contribute to the rehabilitation, replacement or
restoration of human function. Progress or new applications in biomaterials,
especially towards improved performance and relating to the tissue-biomaterial
interface, artificial organs, implants, robotic and orthotic systems and devices,
modelling techniques, artificial neural networks and information technologies.
2.5
Developments in cellular engineering in order to make cellular biology results
transferable and applicable in clinical patient care by utilizing engineering
methods and understanding clinical needs and demands, for instance in the
development of biological substitutes for the restoration or the replacement of
tissue. Basic investigations are clearly needed in this area prior to clinical
application, using new available physical technologies to characterise cell
function. Topics here will include: interaction between cells and mechanical,
magnetic and electrical energy; cell encapsulation and bioreactors; biological
materials and bioartificial organs; tissue engineering; neuronal interfacing,
guidance and networking.
7
sm/mv/wp2nd.en3
AREA 3
BRAIN RESEARCH
OBJECTIVES
The understanding of the neural system and in particular of functions of the brain is
one of the greatest scientific challenges of today and a unique theme of interest to
society in general questioning about the origin of the mind. The applications in
medicine are far-reaching and may contribute to an improvement in the situation of
persons suffering from major neurological and psychosocial disorders. The EU
countries have all assessed the immense economic and social burdens created by
high prevalence mental and neurological illnesses.
Based upon the new capabilities created by molecular biology and genetics, novel
instrumentation and information technology, industry, including SMEs, in all Member
States will benefit from multidisciplinary, transnational collaboration. Both the
European citizen and the European pharmaceutical industry of the next century are
predicted to benefit substantially from the development of drugs and diagnostics.
Furthermore, instrumentation in this field is likely to become a major growth industry
and information technology will interact with basic brain research, for instance
neurolinguistics and artificial vision.
The primary objective research in this area is to understand the functions of the brain
and the basic mechanisms underlying mental and neurological diseases, integrating
molecular, cellular and clinical approaches, with the aim to promote appropriate and
effective treatment and prevention.
The development of new methods of brain imaging combined with computer science
will allow a better characterization of brain structure, function and metabolism and the
mapping of the distribution of proteins and other structures throughout the brain, and
to characterise the anatomical structures associated with cognitive function and their
dysfunction in disease.
RESEARCH TASKS INCLUDE
3.1
Research on the pathophysiology and basic mechanisms leading to disease,
which should integrate the molecular, cellular and clinical mechanisms
underlying the development of mental and neurological diseases. The role of
molecules (e.g. neurotransmitters, peptides, cytokines, growth factors,
hormones) their receptors and signal transduction mechanisms in disease
development.
3.2
Research on nervous system damage and repair.
3.2.1
Mechanisms of cell growth, differentiation and plasticity in neurons and
glia and how these are affected in disease. Factors modulating cell growth and
differentiation.
8
sm/mv/wp2nd.en3
3.2.2
Contribution to the collection of postmortem brain tissue and the
establishment of banks with e.g. molecular probes, reagents, tissue samples,
body fluids for brain research.
3.2.3
Development of therapeutic strategies for damage limitation, regrowth
promotion and repair. Cell and tissue transplantation.
3.3
Establishment of cell cultures and where necessary animal models of the
human brain diseases for the development of therapeutic agents
3.4
3.3.1
Cultured and genetically engineered cells.
3.3.2
strategies.
Animal models of neurological diseases, evaluation of therapeutic
Research on the understanding of the genetic and immunological basis of
mental and neurological diseases
3.4.1
Identification of the genes involved in mental and neurological
diseases. Comparative research on the expression pattern and function of the
abnormal gene and their normal counterparts. Animal models of disease
mechanisms.
3.4.2
Twin, linkage and association studies, interaction of genetic and
environmental factors, mechanisms involved in genetic vulnerability.
3.4.3
Interaction of the immune, endocrine and nervous system, brainblood barrier and NS, inflammatory mediators and diseases of the NS,
therapeutic strategies, interactions between microorganisms, including virus
and prions and brain function.
3.5
Clinical research
Assessment of human physiological and pathophysiological mechanisms relevant to
the development of clinical pathologies. Clinical trials for the treatment of neurological,
sensory and psychiatric disorders, prognosis and progression of these diseases and
the impact of therapeutic procedures. Clinical trials of cognitive therapy and the
development of cognitive and physical approaches to rehabilitation. Neurological
disability and rehabilitation. Functional neurosurgery and protheses.
3.6
Research on brain imaging
Assessment through brain imaging of the morphology, metabolism and function of the
brain in health and disease, including the assessment of the therapeutic effect.
Contribution of brain imaging to the study of distribution and mapping of molecular
structures throughout the brain, including characterization of anatomical structures and
9
sm/mv/wp2nd.en3
psychological mechanisms interacting with cognitive brain function and dysfunction,
and studies of blood/brain barrier function.
3.7
Mechanisms of pain regulation and relief
Neurotransmitters and peptides: interaction and role in nociception. Inflammation and
pain. Assessment of mechanisms of action of new therapies.
3.8
Illicit drugs
Biological effects of illicit drugs on the structure and function of the brain. Role of
genetic and environmental factors on drug seeking behaviour and addiction.
Biological relationship of addictive disorders to mental disorders: comorbidity.
Development of treatments and clarification of adverse effects of drugs on brain
functioning.
3.9
Epidemiological research
Development of combined epidemiological and long-term prevention programmes to
evaluate the impact of neurological and mental diseases, including the identification of
risk factors and implementation of current knowledge, role of psychosocial and
cognitive factors, mechanisms involved in individual and group differences in levels of
disorders, factors involved in recurrence and relapse in affective disorders. Population
based studies on the interaction between genetic, environmental and behavioural
factors in the pathogenesis of neuropsychiatric disorders.
3.10
Cognitive research
Research on memory processes at psychological and neural system levels, cellular
and molecular basis of learning, cognitive and neural mechanisms of motivation and
emotion, establishment of neural networks directed towards the understanding of
neural information processing, establishment of brain databases.
10
sm/mv/wp2nd.en3
AREA 4.1
CANCER RESEARCH
OBJECTIVES
Further improvements in cancer therapy will require integration of the fundamental and
clinical approaches to research, with particular attention to the building of necessary
interactions between cellular, molecular and developmental genetics with oncology
and epidemiology. Greater understanding of the ways in which cell division and
proliferation are controlled, and the isolation of new genetic and environmental factors
which determine and interact with these controls, will in turn allow the development of
new approaches to prevention, early detection and treatment. The study of hosttumour interactions in the context of escape from immune response, and of somatic
gene therapy targeted at cancer cells, are of particular importance because of the
immediate potential impact on cancer treatment.
The approaches of cellular and molecular genetics will be combined with multinational
epidemiological studies, which are essential for identifying the interplay between the
environmental and genetic components determining carcinogenesis.
Clinical research aims at improvement in both diagnosis and treatment of cancer. The
aim should be to bring the same high standard of quality of care to all patients.
Therefore, complementary to more fundamental research, clinical research will also
facilitate the transition of new opportunities into clinical utility. Emphasis on
usefulness, accessibility and feasibility of application to patients with cancer in daily
practice.
RESEARCH TASKS INCLUDE
4.1.1 Molecular mechanisms of tumorigenesis and metastasis, including the
characterization of the genes and proteins responsible for these processes
Defining the genes involved in the positive and negative control of cell
proliferation, differentiation and apoptosis in various types of cells and their
derivatives.
Defining the different genetic and environmental events which lead to
the development of cancers, determining whether these must occur in a
particular order or can occur randomly.
Examining the nature of the genetic and environmental load which leads
to a marked increase in cancer incidence, making use of the environmental
diversity of Europe.
-
Determining the role of infections in tumorigenesis.
11
sm/mv/wp2nd.en3
4.1.2 Control of cellular growth, differentiation and death (apoptosis), and
deregulations predisposing to cancer
Cloning and expressing the genes involved in normal and cancer cell
growth and apoptosis as tools for the development of tumour markers and as
potential therapeutic targets.
Development of cellular models for the study of oncogenes and
antioncogenes in specific tumours.
Developing transgenic models for cancer in which the interaction
between abnormal cellular growth or differentiation and the environment can be
studied in the context of common cancers.
4.1.3 Cell-selective targeting: to explore, and to implement in clinical practice,
techniques which causes preferential destruction of tumour cells
Assessment and clinical testing of non-toxic vehicles for drug delivery
which can be altered to recognise a particular type of cell based upon any cell
surface component.
Development of gene constructs which can accept any gene sequence
and targeting it into the nucleus of a tumour cell so as to allow cell-specific
expression, with selection for rapidly dividing cells.
New antibody modification and selection techniques to allow the rapid
development of very specific antibodies which identify a particular (clonal) cell
type, and their use for the introduction of cytotoxic agents or genes into
tumours in vivo.
Assessment of the effectiveness of existing and novel immune
modulators in the treatment of common cancers.
Identification of tumour specific antigens and the production of antigen
specific tumour vaccines.
4.1.4 In vitro and transgenic animal models for basic research and assessing new
approaches to treatment
Development of cellular models for assessing effect of gene delivery to
delay or correct cell transformation.
Development of transgenic animal models which combine with a degree
of accuracy the interaction between predisposing genetic and enabling
environmental factors in tumorigenesis, which allow the study of varying
environmental factors to alter susceptibility.
-
Development of transgenic models for simple single gene susceptibilities
12
sm/mv/wp2nd.en3
to cancer (such as breast cancer) based upon human data which allow the
evaluation of gene therapy approaches.
Assessment of gene therapy with controlled tumour suppressor genes in
hereditary forms of cancer.
4.1.5 Predisposition, early diagnosis of cancer, and the earlier detection of
metastases, including technological procedures and development of molecular
and cellular reagents.
Development of simple standardised methodologies to determine
genotype simultaneously for a number of tumour suppressor genes.
Coordination of European programmes studying the molecular genetics
of high cancer incidence and predisposition, with clusters information
technology which can be used in many centres and linked centrally.
Development of cheap and rapid imaging procedures (including those
using MRI, CT, PET) which allow standard computerized evaluation of
alterations in normal body patterns associated with an early tumour.
Tests in blood samples with particular genetic alterations which indicate
a high risk of tumour development.
Use of circulatory delivery of reagents specific for the identification of
primary and secondary cancers.
Screening research for early lesions in cancer and the frequency with
which they progress to cancer .
4.1.6 Effectiveness of systemic treatment modalities, including cytotoxic agents and
biological response modifiers as well as newer approaches such as gene
therapy.
Development and assessment of the safety and efficacy of viral, liposome and/or
receptor-mediated approaches to gene therapy for cancer, and whether combination
approaches will provide solutions to any problems of safety and specificity which
become apparent.
4.1.7 Development of methods for rapid analysis of efficacy of new treatment
modalities including assessment of long term effects and cost- effectiveness
Clinical trials: Modification of individual response to radiotherapy by
predisposing genetic factors.
Clinical trials: Assessment of the relationship between stages of
presentation, intervention and outcome
13
sm/mv/wp2nd.en3
Linking of the therapeutic trial registries with the cancer registries to
allow comparison of data. The setting of harmonized criteria for the entry of
patients into trials for new treatments.
Examination of fundamental aspects of cancer gene therapy trials to
determine overall safety validation, where appropriate.
Development of common protocols for delivery, uptake and costeffectiveness of current research into screening programmes.
Assessment of different protocols for treatment of high incidence
cancers cross the European Union, with regard to outcome, psychosocial
acceptability, quality of life, patient involvement and rehabilitation.
4.1.8 Data collections and computerised recording of incidence, treatment and
outcome which allow analysis on a transnational basis.
Development of data base systems for data collections, with userfriendly prompts, which work on compatible software and which ensure
approaches to data collection for common European standards
Research on cancer registries and the methodologies to collect cancer
incidence data in a uniform way.
4.1.9 Assessment of factors contributing to the optimal quality of life including
rehabilitation and terminal care.
Quality of life as a parameter for treatment assessment including
terminal care and rehabilitation, while respecting individual freedom of choice
and the ethical rules seeking to protect human dignity at the end of life and to
ensure that pain is treated at a sufficiently early stage in incurable diseases.
Assessment of the role of palliative care centres in different national and
cultural settings for terminal care.
Assessment on a European basis of growth, educational achievement
and the incidence of subsequent medical problems (including second primary
cancers) in children treated for cancer.
14
sm/mv/wp2nd.en3
AREAS 4.2
RESEARCH
INFECTIOUS DISEASES
ON
AIDS,
TUBERCULOSIS
AND
OTHER
OBJECTIVES
The coordination and concertation of AIDS research at the EU level during the
preceding programme provide a solid foundation upon which to expand the
programme to include the full spectrum of research activities needed to combat the
AIDS threat. In addition, an opportunity is now provided to incorporate in the
programme research on other infectious diseases, and those caused by yet
unidentified infectious agents and prions as well as agents which have re-emerged as
serious pathogens (for example, as a result of the evolution of multi-drug resistant
strains) or opportunistic infections in immunosuppressed patients.
Research in this area will be focused on the integration of basic, clinical and
epidemiological research, with the clear objectives of unravelling pathogenesis,
developing safe and effective vaccines, improving existing and developing new
therapies as well as defining the extent of emerging problems.
RESEARCH TASKS INCLUDE
4.2.1 Viral and immunological research
Research on the genetics, molecular and structural biology of HIV and
other infectious agents, hospital infections including sepsis
Study of the mechanisms of immune pathogenesis in HIV and other
infections and the analysis of immune response after infection
(immunosuppression, immunoprotection and modifications on the
immunological system).
Molecular and biological studies on the genetic variability of HIV and
other pathogens.
-
Promotion of animal experimentation and research on animal models.
Research on tuberculosis and other infections whose expression is
influenced by immune suppression. Analysis of the persistence of pathogens
and their reactivation following immunosuppression.
Research into resistance mechanisms to therapy, the diagnostic tools
and the development of new therapies against resistant pathogens including
hospital infections.
15
sm/mv/wp2nd.en3
4.2.2 Research on the pathogenesis of HIV and other emerging and re-emerging
infections
Research on the host response, pathogenesis, experimental models,
hospital infections and new pathologies, such as prion diseases and other
infectious disease processes.
-
Research on natural resistance to HIV and other infections.
Development of natural history studies, including the definition of
prognostic markers, the progression of infection and the impact of therapeutic
practices.
-
Pathogenesis of tumours in AIDS patients
4.2.3 Human vaccine development
Development of a safe and effective vaccine against HIV and other
infections, including multi-drug resistant bacterial infections and chronic
diseases associated with infectious aetiology.
Establishment of markers to evaluate vaccine efficiency as well as the
follow-up of the activity and development of the disease.
-
Animal experimentation as well as the coordination of its results.
Study of the competence of the immune system in infants, elderly and
immuno-suppressed individuals in response to vaccination.
Study of protection mechanisms against mucosal exposure to HIV and
other infectious pathogens.
Research on the processes involved in inducing mucosal immunity and
the factors which determine immune responsiveness
-
Research to develop new delivery systems
-
Development of suitable animal models for vaccine development
4.2.4 Development of therapeutic agents
-
Research on synthesis and evaluation of therapeutic compounds.
Antiviral drug development for AIDS management, including vaginal
viricides to prevent transmission.
-
Research on gene therapy against AIDS and other infections.
16
sm/mv/wp2nd.en3
4.2.5 Clinical research, including clinical trials
Establishment of networks for the collection and collation of clinical data
on treatment of AIDS and other infectious diseases, in particular on multicentre
clinical trials (to speed up the availability of effective new therapies).
Identification of priorities for therapeutic trials in opportunistic diseases
following immune suppression.
Research on treatment of AIDS and other infectious diseases, prognosis
and progression of these diseases and the impact of therapeutic practices.
-
Study on clinical latency and long term asymptomatic patients.
4.2.6 Disease prevention and epidemiological studies
Development of predictive models using pan-European data and of
common approaches to evaluate preventive activities and their impact in
specific groups.
Development of new specific monitoring systems to determine the
distribution patterns of new infectious diseases, analysis of risk factors for the
development of AIDS, opportunistic diseases, and novel infectious agents.
-
Surveillance of drug-resistant micro-organisms.
4.2.7 Behavioural and socio-economic research
Research into the requirements for caring, including psychosocial and
social care of affected persons and their families.
Research into behaviour and behavioural factors, with particular
reference to assessing prevention measures.
Development of socio-economic models for forecasts and scenarios in
this field.
17
sm/mv/wp2nd.en3
AREA 4.3
CARDIOVASCULAR RESEARCH
OBJECTIVES
Cardiovascular disease e.g. acute myocardial infarction, congestive heart failure and
stroke are still the most frequent causes of death within the population of the EU. To
continue and accelerate the pace of the discoveries of the last decades and translate
these findings into treatment, multidisciplinary cardiovascular research must be
developed. Studies are best and most economically accomplished in a research
setting combining the expertise of physicians and scientists with different backgrounds
in basic and clinical cardiovascular research and in molecular genetics.
In order to obtain major achievements in the treatment and prevention of
cardiovascular disease and stroke, research should focus on the understanding of the
basic mechanisms of disease development assisted by broadly based epidemiological
studies to identify internal and external risk factors, also in conjunction with the brain
research area of this programme.
RESEARCH TASKS INCLUDE
4.3.1 Analysis of the cellular and molecular mechanisms leading to diseases of the
heart and blood vessels, e.g. artherosclerosis and hypertension, including
research on cardiac and vascular growth, injury and repair and cardiovascularassociated inflammation:
Research on cell-cell (e.g. blood/vessel wall interface) interaction.
Characterisation of the role of molecules (auacoids, peptides, growth factors,
cytokines, adhesion molecules, extracellular matrix components, lipids, clotting
factors) and their signal transduction mechanisms in the development of
cardiovascular diseases. Differential expression of surface antigens, receptors,
ion channels in cardiac and vascular cells.
Vascular and cardiac cell growth mechanisms in health and disease.
Cellular remodelling, injury and repair. Research on recovery from injury (e.g.
proteases, free radicals, antioxidants) as well as other regulating mechanisms
that can prevent injury or accelerate functional recovery and repair.
Inflammatory mechanisms and cardiovascular disease.
Biological
mechanisms of atherogenesis and thrombosis (e.g. mechanisms of fibrin
formation and dissolution).
4.3.2 Development of clinically useful agents for injury or excessive growth promotion
that facilitate and promote functional recovery and/or repair (e.g. proteases,
free radical scavengers, growth factors).
18
sm/mv/wp2nd.en3
4.3.3 Research on the understanding of the genetic bases of cardiovascular
diseases and stroke
Identification of the genes involved in cardiovascular disease
development. Genetic predisposition, risk factors, interaction with non-genetic
factors, implications for screening, intervention and prevention studies.
Comparative research on the expression pattern and function of the
abnormal genes and their normal counterparts.
Research on the modifications and/or insertions of genes to prevent or
reverse genetic abnormalities.
4.3.4 Assessment of physiological and pathophysiological mechanisms relevant to
cardiovascular disease development, in particular treatment and prevention
clinical trials, assessment and comparison of relative benefits and costeffectiveness of new and already existing treatments and devices.
4.3.5 Research on imaging and on invasive as well as non-invasive techniques
Assessment of the structure, metabolism and function of the heart and
blood vessels in health and disease and the effect of therapy.
Clinical evaluation of non-invasive methods of diagnosis, comparative
assessment on the ability of different techniques to evaluate clinical conditions,
establishment of registry data on invasive and non-invasive procedures,
development of systems aimed at evaluating the potential effects on outcome
of future technologies.
4.3.6 Identification of risk factors and high risk populations and implementation of
current knowledge, evaluation of the differential distribution of risk factors
among populations, management of risk factors, role of social and ethnic
factors, and interaction of genetic and environmental factors, with a view to long
term prevention.
4.3.7 Relationships between hypertension, cerebrovascular diseases, peripheral
arterial disease and the nature of the interaction of genetic, environmental and
life-style factors in their evolution.
19
sm/mv/wp2nd.en3
AREA 4.4
RESEARCH ON CHRONIC DISEASES, AGEING AND AGERELATED DISEASES
OBJECTIVES
Because of the demographic evolution in Europe and the enormous social and
economic impact of age-related problems in general and chronic diseases, handicaps
and dependency in particular, a focused research effort is needed in conjunction with
the other areas of the programme, (such as biomedical engineering, human genome
research, brain research,etc) in order to promote optimal quality of life and
independence for the elderly and the handicapped.
Research will be conducted on aetiology, including environmental aspects, and
treatment of chronic diseases such as chronic arthritis, diabetes mellitus, respiratory
problems (including asthma). Particular attention will be given to auto-immune
aspects, immuno-genetics and T-cell disorders.
RESEARCH TASKS INCLUDE
4.4.1 Chronic inflammatory diseases
Research on cartilage destruction and immune mechanisms (cellular
and humoral) as being a prospective area for early treatment and prevention.
-
Research on regulation of inflammatory factors of rheumatoid arthritis
-
Investigation of inflammation of the mucosal system
-
Facilitation and coordination of human immunogenetic studies.
Use of the experiences from animal models for the design of
therapeutic experiments in patients and the coordination of and providing
facilities for pre-clinical studies of promising immunotherapy strategies in nonhuman primates.
Coordination at a European level of studies relating to the experimental
basis of new immunotherapeutic modalities.
4.4.2 Insulin and non-insulin dependent diabetes mellitus
Determination of genetic and environmental risk factors leading to
diabetes
Detection of high risk patients by the precise identification of
responsible genes and of the antigen for the detection of specific antibodies.
-
Prevention, treatment and management of diabetes
20
sm/mv/wp2nd.en3
-
Islet cell transplantation
4.4.3 Respiratory problems and asthma
-
Investigation into treatments and management of respiratory problems
-
Genetic disorders relating to respiratory problems
-
Viral and fungal infections and pathogenesis of asthma.
Elucidating the role of environmental factors in the development of
asthma
Mediators of inflammation in asthma (lymphokines, neuropeptides,
arachidonic acid cascade, etc.), including IgE regulation and binding factors,
the proteases antiproteases balance
-
Chronic tissue damage of the bronchial tree
4.4.4 Ageing and handicaps
-
Study of the molecular and cellular mechanisms of ageing and the
alterations linked with the pathologies.
Study of the morbidity and co-morbidity caused by mental, motor and
sensory handicaps and disabilities as a bridge between basic research and
clinical practice, and in conjunction with the brain research area of this
programme.
Identification of associations between disease impairment, functional
limitations and disabilities in elderly people.
Development of new rehabilitation methods, new devices and
appropriate care provisions in order to diminish dependency of the elderly, the
handicapped and those with chronic disorders.
Multinational trial of hormone replacement therapy in post menopausal
women looking at the endpoints of cardiovascular disease, locomotion system
and finality of life.
21
sm/mv/wp2nd.en3
4.4.5 Age-related problems
Aetiology and pathogenesis of congenital and genetic diseases, including
hemoglobinopathies and in particular thalassemia. Evaluation of new protocols and
methods on risk estimation, genetic counselling and possible prevention. Evaluation of
new therapeutic approaches.
Aetiology, pathogenesis of diseases acquired during the pregnancy and
perinatal period. Evaluation of intra uterine diagnosis, prevention and new
therapeutic approaches
Risk determination and prediction of dementia, prevention, and
treatment of age-related mental disorders
Genetical and environmental risk determination, prevention and
treatment of crippling diseases
22
sm/mv/wp2nd.en3
AREA 4.5
HEALTH
RESEARCH ON OCCUPATIONAL AND ENVIRONMENTAL
OBJECTIVES
Research in this area is aiming at improving the scientific knowledge needed to
increase the safety and health protection of the workers, with an emphasis on the
prevention of occupational diseases and accidents at work. The matters to be
considered in particular are:
- identification of important risk factors and their control
- improvement of safety management
- evaluation of economic costs
RESEARCH TASKS INCLUDE
4.5.1. Dose/effect relationship of physical, chemical and biological agents at work with
special attention to low exposure levels, and on the health effects on workers
subject to mixed exposures, including the development of methodologies for
detecting defects.
4.5.2. The interaction between genetic and occupational factors in the aetiology of
diseases.
4.5.3. Epidemiological research to identify specific high risk situations in terms of
diseases and/or accidents at work.
4.5.4. The identification of work situations, the impact of new technologies and
psychosocial factors which give raise to stress or strain related conditions, and
intervention methods needed to combat them.
4.5.5. Impact of the health status of workers on work capacity, and the health
consequences of an aging working population.
4.5.6. Improving the ergonomic aspects of the man/equipment and process interface,
and evaluating the costs and benefits of interventions in e.g., where there is a
particular risk of injury to the back or musculoskeletal system.
4.5.7. Aetiology of occupational accidents and their socio-economic consequences for
individuals, enterprises and society.
23
sm/mv/wp2nd.en3
4.5.8. Interaction between risk factors at the workplace and the environment and
extraprofessional activities, and the aetiology of occupation and environmentalrelated diseases, including musculoskeletal disorders.
4.5.9. Improving the understanding of human factors, i.e. risk perception, attitude and
behaviour of workers and managers, in all aspects of occupational health and
safety.
4.5.10 Research on allergies of public and occupational health importance.
24
sm/mv/wp2nd.en3
AREA 4.6
RARE DISEASES
OBJECTIVES
No country can afford to spend the necessary resources and case mix to implement
basic and clinical research given the low prevalence of rare diseases occurring at
national level. Nevertheless at an EU level as well as at a general scientific level,
these "exceptional" cases turn out to be quite similar and to offer exceptional
experiments by nature to do in-depth research on the basic mechanisms of multiplicity
of rare diseases and handicaps and to offer opportunities to link genetic research with
biomedical and physical expression of disease.
RESEARCH TASKS INCLUDE
4.6.1 Development of basic and clinical research in rare diseases
Definition of diagnostic criteria, causes, pathogenesis, genetic aspects and methods
of prevention of rare diseases, with emphasis on the establishment of
European epidemiological observatories, information networks, and registries
of patients with rare diseases.
4.6.2 Development of educational tools and support to increase information available
to patients, patients support groups, health professionals and to the public on
rare diseases.
25
sm/mv/wp2nd.en3
AREA 5
HUMAN GENOME RESEARCH
OBJECTIVES
The infrastructure and resources established during preceding programmes have to
be consolidated - where appropriate - and to be modified to serve future needs.
Fundamental research in the area of human genome research will be promoted.
Functional studies will be promoted in order to ensure that advances in genetics are
used to enhance human health. Development of appropriate technologies and
applications which contribute to the well-being of patients will be stimulated. Emphasis
will be placed on the promotion of somatic gene therapy where the
conditions/acceptance in Europe justify a targeted effort. Participation of industrial
partners in large-scale projects will be promoted.
Sharing and harmonisation of genome databases will be promoted. The human
genome research will be carried out in close collaboration with other research activities
supported by national or EU programmes. Links will be maintained with appropriate
international organizations or forums (eg the Human Genome Organisation, HUGO).
The programme also aims at increasing the understanding of genome research at all
societal levels by medical professionals, governments, and the general public.
Research aiming at the development of methods suitable for the achievement of any
one of the objectives listed below will be stimulated.
The confidentiality of any personal information collected in the course of the research
must conform to the best data protection practice. No research modifying, or seeking
to modify, the genetic constitution of human beings by alteration of germ cells or at
any stage of embryo development, which may make these alterations hereditary, will
be carried out under this programme. Ethical, legal and social aspects, including
intellectual property rights, shall be dealt with by both programme-specific (biomedical
ethics) and related horizontal activities.
RESEARCH TASKS INCLUDE
5.1
Gene mapping and genome analysis to provide a sequence-ready ordered
collection of fragments of the complete human genome and to identify all genes
with their regulating sequences as well as the non-coding elements with
functional relevance, including research aimed at the exploitation of
comparative approaches.
5.1.1
Construction and validation of high density integrated maps ready
for transcript identification and sequencing.
5.1.2
Developing high throughput
economizing current sequencing technology.
sequencing
methods
and
26
sm/mv/wp2nd.en3
5.1.3 Development and improvement of methods for the systematic
identification of genes in cloned or sequenced genomic DNA and of chromatin
elements of functional relevance other than genes.
5.2
Analysis of gene function and interaction.
5.2.1
Development of cellular and animal models for the better
understanding of gene interaction and gene-environment interaction relevant to
human disorders.
5.2.2
Improvement of techniques for gene targeting, eg construction of
conditional knock-outs.
5.3
Understanding the role of genes and gene products in disease aetiology and
pathogenesis. Development of diagnostic and risk assessment procedures for
clinical use.
5.3.1
Diagnosis and understanding of the pathophysiology of genetic
diseases, including non-genetic factors
5.3.2
Identification of genes involved in multifactorial disorders and
analysis of their mutual interactions, the structure and function of the gene
products and their interaction on non-genetic factors. This includes use of
appropriate cellular and animal models.
5.3.3
Development of protocols for risk estimation of complex disorders
and for genetic counselling.
5.4
Somatic gene therapy: to establish a scientific basis which will contribute to the
improvement of gene replacement and repair of human cells.
5.4.1
Development of new methods and improvement of existing ones
to deliver genes safely and effectively for therapeutic purposes in specific
diseases.
5.4.2
Development of tools to assess and monitor the benefit of
somatic gene therapy.
5.5
Information management and analysis.
5.5.1 Development and application of database, and software technology for the
management, integration and sharing of genome data.
27
sm/mv/wp2nd.en3
5.5.2
Development of theoretical models for the analysis and
understanding of genome data.
5.5.3
research.
Development of software to facilitate experimental genome
5.5.4
Promotion of forums for the communication and exchange of
global human genome understanding.
28
sm/mv/wp2nd.en3
AREA 6
PUBLIC HEALTH
SERVICES RESEARCH
RESEARCH,
INCLUDING
HEALTH
OBJECTIVES
All health systems, whatever their organisation and financing mechanisms must react
to the rising health care demand and at the same time contain the health care
expenditure.
The general aim of health services and public health research is to contribute to
resolving the common problems which affect European health systems and which can
affect the attainment of a high level of health status for the population.
This area will also underpin the initiatives taken in the context of the newly introduced
Article 129 of the Treaty on the European Union.
Research in this field will be focused on the following research tasks:
RESEARCH TASKS INCLUDE
6.1
Research on methodologies linked to health data on demographic changes,
morbidity and mortality in the general population and in specific groups, such as
socially deprived groups, in order to identify the health needs, using new
indicators as appropriate. Research on new health indicators related to health
objectives, harmonisation of methods of data collection and analysis.
6.2
Research on health determinants, including risk factors and protective factors
and on methods for evaluation of the effectiveness of prevention strategies,
e.g. vaccination, including health education, in the Member States.
6.3
Assessment of the socio-economic impact and performance measurement of
health policy initiatives, including socioeconomic variations in health and the
development of health information systems.
6.4
Economics and organizational aspects of health systems and the provision of
services, their regulation and de-regulation, the balance between private and
public health care funding and their impact on health indicators, accessibility,
equity, effectiveness and quality of health care delivery.
6.5
Research on the efficiency and the quality of health care delivery through the
development of strategies for improving the quality of care, and the
establishment of a quality culture in European health care institutions.
6.6
Development of strategies to identify new emerging technologies and to assess
their effectiveness and cost in order to define a European approach for their
introduction into health care services.
6.7
Identification of models for assessment of health needs and demands, and for
29
sm/mv/wp2nd.en3
trend setting and planning in the field of public health. Development of major
comparative population-based studies and studies of interventions (treatments
health promotion programmes and behavioural and social intentions) designed
to reduce dependence and enhance the quality of life.
6.8
Assessment of the impact of the internal market on the health care systems,
health needs, demands and care delivery.
30
sm/mv/wp2nd.en3
AREA 7
RESEARCH ON BIOMEDICAL ETHICS
OBJECTIVES
Research on biomedical ethics will address general standards for the respect of
human dignity and the protection of the individual in the context of biomedical research
and its clinical applications. The social impact and the public awareness of the
problems associated with biomedical progress will be addressed. The global
objectives of this area are similar to those described in the horizontal activities (8.1),
ethical, legal and social aspects (ELSA). The research activities carried out in this
area and these carried out within the horizontal activities ELSA will be performed
jointly in order to benefit from interdisciplinary competence.
Measures will be taken to develop fundamental and applied research in biomedical
ethics and to promote the participation of all partners active in this area (universities,
hospitals, research centres, bioethics institutes, patients and health care
associations).
The tasks listed below are more directly related to medical and health research and its
applications from the patient/doctor perspective, those described in 8.1 are more
directly related to social and legal approaches from the societal perspective.
RESEARCH TASKS INCLUDE
The ethical aspects of the research activities within areas 1 to 6 in particular:
Medically assisted procreation,
including gametes selection,
preimplantation and prenatal diagnosis, research on the human embryo,
sperm and egg donation and their possible conservation, and on contraception.
Human genome research and its clinical applications, including testing,
screening and therapy, in particular multifactorial diseases and genetic
screening at workplace, and genetics of population.
Ethical aspects of brain research and neurosciences, including
treatment which modifies behaviour, and microelectronic implants.
End of life issues, including palliative care, artificial prolongation of life
by advanced medical techniques, resuscitation, the treatment of pain in the
terminal phase and euthanasia.
Organ and tissue transplantation, including the use of human cells,
tissues (including foetal ovarian tissue) and organs, as well as xeno-transplant
and issues concerning tissue and organ banks.
31
sm/mv/wp2nd.en3
Patient's consent and autonomy: informed consent of the individual to
diagnosis, therapy prevention or research, including the consent of vulnerable
populations, e.g. prisoners and cognitively impaired patients.
Ethical aspects of research methodologies (for instance, animal
experimentation, transgenic animals, use of non human primates, and
alternative, specific problems of multicentre clinical trials and clinical trials in
developing countries.)
Ethical aspects of medical decision-making process, for instance,
neonatal intensive care, or emergency situations.
32
sm/mv/wp2nd.en3
AREA 8
8.1.
HORIZONTAL ACTIVITIES
ETHICAL, LEGAL AND SOCIAL ASPECTS (ELSA)
OBJECTIVES
To analyze the ethical, social and legal issues raised by specific
applications of biomedicine and health research with a view to their being
taken into account in public policy deliberations.
To promote a rational and balanced dialogue between the key players
including experts from natural sciences, medicine, philosophy, theology, law,
economics, history and social sciences; and to involve the general public in this
debate through, e.g. consumer and patients groups, industry and trade unions.
To understand and answer public attitudes and diversity of viewpoints,
in particular the fundamental values which are the basis of the differences and
similarities in the perception of ethical issues.
To identify the fundamental values that could be a basis for a possible
consensus.
To recognize and appreciate cultural differences in Europe: the role of
active tolerance and the positive aspects o ethical dissent in pluralistic,
multicultural and pluri-ethnic societies (including migrant cultures).
To fulfil a prospective role, anticipate the problems and provide early
warnings for new ethical/social issues.
Research activities on Biomedical Ethics (Area 7 of this programme) and the
horizontal activities on Ethical, Legal and Social Aspects (Area 8.1) will be performed
jointly, in order to benefit from interdisciplinary competencies and to ensure synergies
throughout the three life sciences and technologies programmes and activities in other
frameworks.
RESEARCH TASKS INCLUDE
Fundamental values (for instance, human dignity and integrity, consent
autonomy and privacy, freedom and responsibility, concepts of risk, solidarity
and social justice).
-
Embryo and foetus protection from the societal point of view.
Methodologies and structures in bioethics: research on ethics bodies in
Europe: public debate and public awareness activities: consensus
conferences, exchange of experiences, opinion surveys, etc, compilation and
assessment of comparative regulations; data bases and infrastructures.
Multidisciplinary methodologies and transcultural approaches to solving ELSA
33
sm/mv/wp2nd.en3
issues.
-
Social uses (e.g. forensic) of human genome research.
-
Legal and ethical rules of research for pharmaceutical drugs.
Confidentiality and privacy in medical data, genetic and non-genetic
with emphasis on the specific problem raised by modern information systems
such as computerization with automatic data transfer.
Intellectual property rights, in particular for the human genome, data
banks and the legal protection of biotechnological inventions.
Resource allocation: ethical and social dimensions of the choices to be
made concerning health budgets.
Ethics of prevention, insurance and other socioeconomic and legal
aspects of resource allocation and priorities in health care.
Impact assessment of medical and health research
societal values.
discoveries on
Legal protection of animals and the public debate concerning their
scientific use.
Respect for the fundamental principles of the European Convention for the Protection
of Human Rights, the United Nations Declaration of Human Rights and the future
Bioethics Convention of the Council of Europe, will be ensured through medical and
health research funded by the European Community, which will apply the 4th
Framework Programme prohibitions of germ-line therapy
or human nucleus
replacement, known as cloning, as well as monitoring of general and specific risk
evaluation in projects. Areas where detailed expert opinions and reports are required
will be identified: targeted workshops and publications of these opinions and reports
will be encouraged. As appropriate, working groups will be set up to advice the
Commission and to report to the Council and to the European Parliament.
A link will be established with the new European Technology Assessment Network.
which will aim to coordinate the Community's research in the field of socio-economic
research. An important aim for bioethics research should also be to avoid duplication
by bringing together those concerned and maintaining up-to- date information on past,
present and future activities.
34
sm/mv/wp2nd.en3
8.2
DEMONSTRATION PROJECTS
Demonstration projects in this programme (see definition in section II.2.3.,
Implementation Modalities) represent a new modality of implementation with
potentially important implications for researchers and technologists active in the broad
field of Biomedicine and Health. For this reason, a careful approach will be taken;
demonstration projects will be implemented by means of shared-cost actions and will
be selected in specific target areas which have been identified as those in which both,
techno-economic risks are high, and European strengths of critical mass are needed.
Such target areas include new techniques for functional and interventional imaging, for
minimally invasive surgery, for patient monitoring in intensive care (e.g., chemical
sensors, smart active electrodes, signal interpretation and intelligent monitoring),
implantable systems (for e.g., neuro-stimulation, or cardiac defibrillation) and
implantable devices for drug-delivery. New cancer therapies (including somatic gene
therapies), new vaccines, new therapeutic practices or new diagnostics systems,
specially those based on genome technologies and somatic gene therapies to treat
conditions different from cancer.
The aims of demonstration in the context of this programme are i) to speed up the
adoption of new technologies, methodologies or therapeutic practices by reducing the
techno-economic uncertainties and risks associated with innovation and ii) to enhance
the attractiveness of new approaches in the medical community, industries and
services, contributing to the message that new technologies and therapeutic practices
are developed for the benefit of society as a whole.
In demonstration projects the resources and interdisciplinary skills of producers of new
technologies, methodologies or clinical practices will be combined with those of the
users or clinicians to show, on a meaningful scale of operations (i.e., the minimum
scale required to obtain reliable information), the techno- and socio-economic
advantages offered by state of the art concepts with respect to existing ones.
A demonstration project will entail the evaluation of the performance of a new
technology, device or therapeutic approach under realistic operating conditions;
however the actual scale at which projects will be implemented will depend on the
specific nature of the problem. Thus, the construction and testing of just one prototype
(e.g., a novel irradiator for cancer therapy) may fulfil the objective of the demonstration
project while, in other cases, several prototypes (e.g., new chemical sensors or drugrelease devices) will be required in order to test the technology across the Community
under an adequate diversity of circumstances. For new bio-medical products or
therapies, multicentre pilot testing in Europe (i.e., preceding full scale clinical trials) will
be the maximum scale allowed within the scope of demonstration considered by this
programme. All elements necessary to implement the demonstration project must be
ready and available to the proposers. No research or technology development
activities will be accepted within a demonstration project.
Efforts should be made to keep the cost of projects at reasonable levels. For instance
subcontracting of existing industrial or pilot facilities should be considered, rather than
the construction of new ones. In general, the maximum Commission contribution to
35
sm/mv/wp2nd.en3
demonstration projects will be of 2 MECU for the largest projects. Individual
contributions to each of the project participants must reflect a good balance amongst
their respective tasks and responsibilities within the project.
Partnerships executing demonstration projects should have a clear vision of the
exploitation of project-deliverables and/or a clear commitment to provide reliable
information to public entities such as consumer and patients associations, Public
Health services, regulatory bodies, industrial and professional groupings, etc. Priority
will be given to projects addressing the hurdles which hamper the use of new
technologies, methodologies or therapeutic practices; such hurdles can include the
need of industry to have a positive statement from the biomedical community that the
implementation of that new technology or practice is indeed needed in patient care,
the existence of competing technological alternatives or treatments, the frequently
encountered reluctance to change established practices by novel approaches, and a
sometimes negative public perception of modern genetic technologies.
Whenever possible, and in accordance with the terms and conditions established in
the Commission Model RTD contract to guarantee the intellectual property and
exploitation rights of contractors, industrial platforms or, in a more general sense,
platforms of users, will be associated with these demonstration projects in order to
provide the project with an "extended audience". These platforms should serve to
show the techno-economic advantages of new technologies to the widest possible
range of users and to facilitate technology transfer and the adaptation of new
technologies to local conditions.
Demonstration projects must have a strong user's need orientation and will always
involve the participation of the medical profession. The required integration of
technology producers and technology users in consortia of sufficient critical mass for
project implementation is justified by the need to guarantee, on the one hand, a clear
technological objective, and on the other hand, a significant commitment to using the
new technology or therapeutic practice once its demonstration has been successfully
accomplished. Technical excellence and novelty, economic outlook (both in terms of
benefits and/or in terms of cost-effectiveness for the Public Health Services), a
sufficient level of prior knowledge about the new technology or clinical practice, and an
appropriate experience and mix of expertise on the part of the executing partnership,
will be required.
36
sm/mv/wp2nd.en3
II.
IMPLEMENTATION OF THE WORKPROGRAMME
Implementation modalities
This programme will be implemented through concertation actions, shared cost
actions, specific measures, preparatory, accompanying and support measures.
Participation of international organizations may be financed in exceptional cases on
the same basis as that of legal entities established in the Community.
Proposals can be formulated for a time period of maximum 36 months.
1.
Concertation
1.1
Concerted actions (CA) are designed to encourage collaboration between
teams of interested researchers, bringing together their accumulated expertise
in a research network to find solutions to those medical or health problems
which are common to all European Member States but which are more likely to
be solved by European collaboration. This is the essence of the BIOMED
programme, which is to support research projects only where the Member
States can be more effective by working together than they would be alone,
thus both observing the basic principle of subsidiarity and creating European
added value.
Concerted actions are considered for example where the pooling of data facilitates
common interpretation of data and contributes to the basis for the development
of harmonized standards, procedures and common research instruments, or
where coordination of work is a prerequisite to the possible launching of
shared-cost projects at a later stage. They may also be used to foster the
interaction of basic and clinical research or to bring together primary producers,
manufacturers, end-users, universities and research centers around the same
technological objective, in order to facilitate mobility of researches and to
ensure that greater account is taken of market needs.
Each network has a project leader whose task is to coordinate, together with the CA
steering group, the activities carried out by the various research teams towards
the defined objectives and targets.
The cost of Concerted Actions is funded from local sources within individual Member
States, either in the form of public or private grants of from the teams'own
resources, with the Community providing the additional cost of working on a
European basis. Community funding will cover up to 100% of the costs of
concertation as follows:
-administrative and scientific support flowing directly from the needs of the concerted
action, i.e. the building and managing of the research network for joint data
gathering and/or experiments
organizing meetings of all types
short-term international staff exchanges
37
sm/mv/wp2nd.en3
-
preparing and exchanging reference materials
centralized data handling
disseminating information and results
Past experience has shown that Community appropriations have constituted less than
5% of the total cost of the Concerted Action, giving a "CA multiplier effect" of 20 to 1.
In order to achieve the specific objectives and targets of the Concerted Action, it may
be reinforced in the following ways (Reinforced Concertation):
.
by the provision of a network resource within the Concerted Action to
provide specialized quality control products, experimental materials or
specialized services including teaching and training for the specific purposes of
the Concerted Action (see section 3.2 below)
.
by the addition of targeted training and mobility of young researchers
and technical staff needed for the specific purposes of the Concerted Action. In
such cases the EU will provide support for bench fees at the host laboratory
and return grants in the form of laboratory materials and equipment for
continued cooperation after the return of the trainee to their laboratory of origin.
1.2
Community Contribution: The Community contribution to Concerted Actions
will not exceed 100,000 ECUs per year in total, or 250,000 ECUs per year in
total when fully reinforced, as follows:
Concerted Action
up to 100,000 ECU/year
+
network resource
up to 50,000 ECU/year
+
targeted research training
up to 50,000 ECU/year
+
return grants for trainees to laboratory of origin up to 50,000 ECU/year
----------------------------up to 250,000 ECU/year
2.
Shared-cost actions
Except where indicated the Community contribution will not normally exceed 50% of
the total cost of the project, with progressively funding for industry the nearer the
project is to the market place. Those universities and similar institutions which do not
have analytical budget accountancy will be reimbursed on the basis of up to 100% of
the allowable additional costs.
2.1
Shared-cost RTD projects carried out by (health) undertakings, research
centers and universities; they may of may not include industrial firms in the
partnership. These projects represent a standard organization of transnational
shared-cost research in multipartner structures, commonly known as
"European Laboratories without Walls". They must include at least two non
affiliated legal entities from two different Member States. The contribution of the
Community for RTD projects shall normally correspond to the support of up to
38
sm/mv/wp2nd.en3
one or two full-time equivalent/year in each participating legal entity. Once
selected they should be implemented without rearrangements nor substantial
changes to the proposed partnership.
2.2
Technology stimulation for SMEs to encourage and facilitate participation of
SMEs in RTD activities: proposals may be submitted at any time during the
period covered by the work programme.
(i)
Preparatory awards for carrying our the exploratory phase of an RTD activity,
including the search for partners, during a period of up to 12 months. The
award will be granted following the selection of an outline proposal to be
submitted normally by at least two non-affiliated SMEs from two Member
States. The award will cover up to 75% of the cost of the exploratory phase,
without exceeding 45,000 ECU or 22,500 ECU in the exceptional case of a
single applicant SME. The prime proposer must be an industrial SME.
(ii)
Cooperative research projects whereby SMEs (including where appropriate
health care institutions), having similar problems but without adequate research
facilities of their own, engage other legal entities to carry out RTD on their
behalf. Projects will normally involve at least 4 non-affiliated SMEs (including
where appropriate health institutions!ions) from at least two different Member
States. Community funding will normally cover 50% of the cost of the research.
2.3
Demonstration Projects
The objective of a demonstration project is to prove the technical viability of a new
biomedical technology, methodology or recently proposed therapeutic practice,
together with, as appropriate, its possible economic advantages, including its
contribution to the efficiency of Health Services in Europe. The projects will be
precompetitive and, should as such focus on the application of new technologies or
practices and involve participation by both technology producers, technology users
and medical practitioners (physicians, clinicians, etc.). A detailed description of the
objectives of and criteria for demonstration projects can be found in section 8.2 above.
Community funding is likely to be no more than 2 million ECU for the largest
demonstration projects.
3.
Specific measures appropriate to BIOMED programme
3.1
Centralized facility, defined under this programme as a unique general service
tool for other concerted or shared cost actions supported by the Programme in
order to enable standardization, joint experiments, data collection and analysis,
with access to particular quality control products, experimental materials or
specialized services. Community funding may cover up to 100% of the costs of
services rendered by the Centralized Facility to the research center,
universities, undertakings and enterprises participating in shared cost and
concerted actions.
39
sm/mv/wp2nd.en3
3.2
Reinforced concertation: See Section 1.2 above. Community funding may
cover up to 100% of these costs.
4.
Individual Fellowships
Activities relating to Research fellowships linked to the specific targets of the
Biomedical and Health research Programme will be undertaken in order to enhance
scientific skills and expertise. This activity will also serve to facilitate technology
transfer to the health care related industries.
40
sm/mv/wp2nd.en3